Health TrialsbyHealthPanel

Observational Study of Venus P-Valve

ConditionRight Ventricular Outflow Tract Dysfunction
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12-70
SponsorVenus MedTech (HangZhou) Inc.

About this trial

Real-world evidence, retrospective and prospective, non-randomized, multicenter observational study of VenusP-ValveTM System in treating moderate or greater pulmonary regurgitation with/without pulmonary stenosis in patients with native right ventricular outflow tract (RVOT).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with native RVOT (including transvalvular patch repair) are present with moderate or greater pulmonary regurgitation with/without stenosis and are clinically indicated for pulmonary valve intervention.

The patient (or the patient's legally authorized representative) is willing to consent to participate in the study and will commit to completing all follow-up requirements.

Disqualifiers

None

Trial population

Baseline enrolment criteria * 12 years old up to 70 years old * Weight ≥ 30kg * With evidence of moderate or severe (≥3+) pulmonary regurgitation by Transthoracic Echocardiography (TTE) * With \>30% pulmonary regurgitation fraction as defined by cardiac Magnetic Resonance Imaging (MRI) * The subject is symptomatic from his/her pulmonary regurgitation or meets MRI criteria for intervention Right Ventricular Ejection Fraction (RVEF) \< 45%, Pulmonary Regurgitant Fraction (PRRF) \>30% and increased Right Ventricular End Diastolic Volume (RVEDV) Index (RVEDVI) \>150mL/m²

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • transcatheter pulmonary valve implantation (TPVI)

    Device

    A stent-mounted valve is introduced over a guidewire and positioned in the RVOT, followed by balloon inflation to deploy the valve.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Non-hierarchical composite endpoint

* Freedom from VenusP-ValveTM (catheter or surgical) reintervention * Acceptable hemodynamic function, defined as: 1. Mild or less regurgitation measured by echocardiography; AND 2. Mean RVOT gradient as measured by echocardiography ≤35mmHg.

Time frame
at six months

Secondary outcomes

1

Procedural Success

Procedure success at 30 days, defined as: * Freedom from procedure/device-related mortality * Freedom from Venus P-ValveTM (catheter or surgical) reintervention concerning index procedure or device * Acceptable hemodynamic function * Original intended valve in situ

Time frame
at 30 days
2

Occurrence of Events

Occurrence of the following events through 5 years of follow-up: * All-cause mortality and procedure/device-related mortality * Venus P-ValveTM (catheter or surgical) reintervention * Venus P-ValveTM dysfunction * Serious procedure/device-related adverse events

Time frame
through five years
3

Functional status

New York Heart Association (NYHA) classification out to 5 years

Time frame
through five years
4

Health-state utility score

Health-state utility score as measured by the EQ-5D at pre-implant, 30 days, 6 months, 1 year and annually thereafter through 5 years.

Time frame
through five years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Venus MedTech (HangZhou) Inc.

Lead sponsor

IQVIA MedTech BV of Antwerp, Belgium

Collaborator

MDCECRO LLC

Collaborator

Source ClinicalTrials.gov
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